Like others, we have been intrigued by the speed and scale of devastation in India. So we tried to understand some more on an emerging variant of SARS-Cov-2 in the country. What sparked our interest, even more, was a Reuters report that cites Indian scientists seriously concerned about the process around collection and sharing of epidemiological data. This likely will have an impact on how this variant is understood globally. Read a response from WHO below on a question we raised this week.
We understand that our exclusive story from last week: Countries Divided On How To Reform Who Emergency Response: What This Tells Us About The Pandemic Treaty Discussions, has likely upset some sections of civil society. We mentioned the different motivations for supporting the discussions on a pandemic treaty. Irrespective of our personal politics, we are obliged to reflect dynamics among global health actors including the civil society. By bringing a range of diverse opinions to our readers, we inform how these crucial discussions are shaping up. We are happy to be playing an active role in an evolving conversation.
While we are not shy of taking positions, when we do so, we state it directly without ambiguity. We may not agree with all the opinions reported and stated in the course of our work, but it is our duty to reflect the important nuances especially if they reveal implicit power structures.
Finally, some of you have also written to us inquiring about our loved ones in India. Thank you for writing and sharing our concerns. We truly appreciate it in these times that are difficult for much of the world.
Later today, we will be moderating a discussion on the TRIPS waiver proposal at an event organized by a few civil society organizations, that will feature a former president, senators, Parliamentarians, and ambassadors. One can register for the event here.
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I. POLICY UPDATES
SARS-CoV-2: The variants of concern (VOC) and the variants of interest (VOI)
The SARS-CoV-2 variant B.1.617 present in India and other countries has been designated as a variant of concern despite the on-going surge of infections and mortality in India. We wanted to understand why this wasn’t a variant of concern yet. Is this due to an alleged lack of sufficient information collection and sharing of important data in India. This variant was first detected in October 2020.
In its weekly epidemiological update, WHO said on April 27:
In India, heterogeneity in B.1.617 geographic distribution is observed across regions, with co-circulation of other VOCs (including VOC 202012/01 and 501Y.V2) and other variants (e.g., B.1.618), which collectively may be playing a role in the current resurgence in this country. Indeed, studies have highlighted that the spread of the second wave has been much faster than the first. 50 Preliminary modelling by WHO based on sequences submitted to GISAID suggest that B.1.617 has a higher growth rate than other circulating variants in India, suggesting potential increased transmissibility, with other co-circulating variants also demonstrating increased transmissibility. Other drivers may include challenges around the implementation and adherence 8 to public health and social measures (PHSM), and social gatherings (including mass gatherings during cultural and religious celebrations, and elections). Further investigation is needed to understand the relative contribution of these factors.
This week, we asked Dr Maria Van Kerkhove, WHO Technical Lead on COVID-19 to tell us more about these distinction between these variants and on the lack of enough information on the B.1.617 variant in India. This is what she had to say:
Yes, indeed, the B.1.617 has been classified as a variant of interest. What WHO does is we have characterizations of variants of concern and variants of interest at a global level. So currently we have three variants of concern at the global level. The B.1.1.7 first identified in the UK, the B.1.351 identified in South Africa and the P.1 first identified in Japan from travelers from Brazil.
We have an additional seven variants of interest that we are tracking worldwide. B.1.617 is one of those. Indeed, there actually are a number of virus variants that are being detected around the world, all of which we need to properly assess. This is based on information that we know about its circulation.
How much of these virus variants are circulating and this is determined by the sequencing capacities in country. And as you know, the sequencing capacity is around the world vary. In India in particular, the sequencing capacities are increasing, as is happening around the world, although we don't have very good eyes and ears to see which of these variants are circulating where. It is really patchy so far.
But there are other pieces of information that we are looking at. We are looking at the epidemiology in the local settings... in terms of.. is there an increasing trend in cases in ICU, hospitalizations. We are also looking at severity. And then there are a number of lab studies that are underway. So we have a global group of individuals who work together, who meet regularly as part of our Virus Evolution Working Group.
The B.1.617 has been discussed with our Virus Evolution Working Group together with colleagues from India to assess what this variant is and and if there are any changes in terms of the epidemiology, in the severity of disease that is caused by in people who are infected with this. Some of these studies take time to understand if there is an impact on neutralization, if there is any impact on our ability to detect it with currently available diagnostics, if there is any impact on the available therapeutics or vaccines.
So there are a number of studies that are underway for the B.1.617 as well as the B.1.618 and other virus variants that are circulating. In addition to that, not only do we look at particular variants, but we are looking at specific mutations that are identified in each of these variants and there are common mutations that are being identified. So what is important, by having this global community speak together as an overarching ability globally to monitor and assess these variants, we are putting the right people together in the room to discuss what do these mutations mean.
It's a very dynamic process. The information is coming in fast and furious. There are new variants everyday that are being identified that are being reported. Not all of which are important. So, it's important that we have the proper discussions, to determine which ones are of significance, from a public health value. Meaning, does it change our ability to use public health and social measures or any of our medical countermeasures. So this is one that we are actively tracking. We are working with colleagues in India but the B.1.617 is also in other countries. So other countries are also doing studies on this particular variant.
Gavi signs up Moderna for the COVAX Facility
In an announcement this week, Gavi said that it had signed an advance purchase agreement with Moderna for its mRNA vaccine for 500 million doses. (Last week, WHO gave Emergency Use Listing to Moderna’s COVID-19 vaccine)
We find it pertinent to note that CEPI’s initial investment for this vaccine was made in January 2020, but AMC-eligible countries will get access to the doses only towards the end of 2021, and mostly only next year. See below.
The Moderna vaccine has recently received WHO Emergency Use Listing, making it eligible to be supplied to COVAX Facility participants. Supply via this APA is expected to commence in Q4 2021, with a total of 34 million doses available in 2021 and up to 466 million doses in 2022. The agreement also contains options to potentially access doses of variant-adapted vaccine in the future.
Moderna’s vaccine is part of the COVAX R&D portfolio. In January 2020, COVAX co-lead CEPI provided initial investment in Moderna’s COVID-19 vaccine programme to support production of the first clinical trial materials.
“CEPI’s early investment in Moderna’s vaccine development programme helped to get the project off the ground, so I’m proud that the vaccine will be made available to protect people in countries around the world through COVAX,” said CEPI CEO Dr Richard Hatchett. “This highly effective vaccine is already saving lives, and will play a vital role in the global control of COVID-19.”
While it is not clear whether this bill adopted by the Brazilian Senate will eventually pass muster, it nevertheless raises questions on Brazil’s opposition to the TRIPS waiver proposal at WTO.
Felipe Carvalho, Country Advocacy Coordinator at MSF in Brazil told us:
“This is an important step because it adapts the compulsory license procedure to national health emergencies, including Covid-19, ensuring that a wide range of technologies are included in one single act, enforcing the sharing of relevant technical information hold by patent owners, establishing clear deadlines for decisions to be made by the Executive power and creating more scrutiny over patents and patent applications related to essential products. It is a clear sign that Brazil's parliament is aligned with the growing global movement calling for no monopolies during pandemics and its an historical decision that helps to rebuilds Brazil's global health footstep. In the day when the country reached more than 400,000 deaths, this is a concrete response by the Senate to address the constraints that intellectual property protections are creating over the supply of essential drugs, diagnostics and vaccines to the Brazilian population.”
II. WHAT WE FOUND INTERESTING
Fauci warns against discarding trade rules on Covid vaccines: Financial Times
“Dr Anthony Fauci, the chief medical adviser to the US president, told the Financial Times that he would oppose a plan to rip up international trade rules in hopes of improve vaccine supply in the developing world if it took too long to bear fruit.”
Damning. With consequences.
“..The warning about the new variant in early March was issued by the Indian SARS-CoV-2 Genetics Consortium, or INSACOG. It was conveyed to a top official who reports directly to the prime minister, according to one of the scientists, the director of a research centre in northern India who spoke on condition of anonymity. Reuters could not determine whether the INSACOG findings were passed on to Modi himself.
Modi’s office did not respond to a request for comment from Reuters.
…INSACOG was set up as a forum of scientific advisers by the government in late December specifically to detect genomic variants of the coronavirus that might threaten public health. INSACOG brings together 10 national laboratories capable of studying virus variants.
…"Policy has to be based on evidence and not the other way around," he told Reuters. “I am worried that science was not taken into account to drive policy. But I know where my jurisdiction stops. As scientists we provide the evidence, policymaking is the job of the government.”
As an Indian, I found it very difficult to read this report that puts in context the massive policy failure in the country.
“Some speculated India may have naturally reached herd immunity. It was a tantalising idea that took hold in India’s highest circles of policymaking, media and science – even a government-commissioned study suggested herd immunity may indeed have been achieved. It would prove one of the most fatal miscalculations of the Covid-19 pandemic so far.”
…Alongside warnings that people should maintain precautions, governments at all levels relaxed restrictions, allowed massive social events to resume and pressed ahead with raucous electioneering, confident the continued circulation of Covid-19 in states such as Kerala or Maharashtra were the dying embers of the virus, not evidence of the sparks that would ignite a second firestorm….
“C-TAP officials met privately over the past year with representatives from Moderna and BioNTech, among other private sector players, to describe the potential for public health gain, according to meeting minutes reviewed by The Times.
The mRNA-based vaccines are, in some ways, ideal candidates for global scale-up: Both Moderna and Pfizer-BioNTech shots showed stunningly high efficacy figures and, because they’re programmed with a genetic code, they’re easily adaptable to new strains that arise.
But the vaccine companies are wary of handing over their trade secrets to any WHO-designated manufacturer, preferring instead to enter into licensing agreements with a more limited number of production facilities they choose.”
Los Angeles Times
And see related FT story from last month: Vaccine patent gives US government ‘leverage’ over manufacturers
There is no question that vaccine donations will be insufficient given the scale of the demand. In addition, it is an inefficient policy response for a problem that is already out of hand.
“With just over 10 vaccinations administered per 100 people in India, compared with 71 in the U.K. and 70 in the U.S., it’s clear that equitable distribution of vaccines is still a pipe dream. By any account, the optics are terrible — healthy younger people being vaccinated in the U.K., U.S. and EU as funeral pyres rage in India.
This disconnect has led to urgent calls for countries vaccinating quickly to donate doses to India. And in some cases, it's followed by action. After a call between U.S. President Joe Biden and Indian Prime Minister Narendra Modi, Washington promised to share its 60 million doses of the Oxford/AstraZeneca jab — which has not yet been authorized in the U.S. — with the world.”
The changing dynamics of vaccine diplomacy and more.
“In contrast to the vaccine shortage in India, Sinopharm’s manufacturers claim that they have already sent 50 million vaccines to other countries, according to a report published last week.
By the end of February, China said that it had supplied 69 countries with vaccines – some as donations as some as sales. Recipients include Zimbabwe, Guinea, Egypt, Pakistan, Serbia, the Maldives, and the United Arab Emirates.
Meanwhile, Botswana announced this week that it had bought 200,000 Sinopharm doses to supplement a donation of the same amount.
Bangladesh also turned to China this week after being forced to suspend its vaccination programme when India told the country that it could not deliver its second batch of AstraZeneca vaccines to it any time soon. Six million Bangladeshis have already received one dose of the AstraZeneca vaccine.
China has offered to give Bangladesh 600,000 doses as a donation and the country will buy the rest. However, the cost of Chinese vaccines could cripple LMICs.”
Health Policy Watch
A must-read story on behind-the-scenes at WHO’s event for Brazil last week.
Along with a social media storm, the appearance also sent ripples through WHO’s ranks – which has a significant constituency of Brazilian and Latin American technical staff posted not only in the region, but across the worldwide organization.
As one senior WHO scientist told Health Policy Watch: “I am nauseated. What has been done right in this pandemic in Brazil has been done despite the national government.”
He added that there was a parliamentary inquiry into the role of the president in the pandemic, but “it looks like WHO is backing the government. Why? It only makes our work more difficult”.
Health Policy Watch
The election season in global health has arrived.
“Tedros’ term as director-general has been engulfed in major health emergencies. A year after he took office, Ebola exploded in what is effectively a war zone in the northeastern corner of the Democratic Republic of the Congo; the outbreak, the second largest on record, took two years to contain. Before it could be fully extinguished, the Covid-19 pandemic began…
…Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law at Georgetown Law, was not a Tedros supporter in 2017, but has since changed his view.
“It would be exceedingly unwise in my view to change DG in the midst of a historic pandemic, which will still likely be raging,” Gostin said in an email. “I also think Tedros has earned another term.”"
A glimpse into pricing decisions on vaccines going forward.
FROM THE JOURNALS / REPORTS:
Morals and the Vaccine Market: Project Syndicate
A take on the vaccines market from the noted economist, game-theory champion, Kaushik Basu.
“We sorely need a theoretical framework to understand this market. Currently, it resembles what oligopoly must have looked like before Augustin Cournot captured its essentials in 1838. Cournot’s breakthrough later enabled the development of the first antitrust laws, like the US Sherman Antitrust Act of 1890, which allowed firms to set prices but prohibited secret multilateral deals to prop up prices. These laws gradually became sharper.
Today, we are making vaccine-market rules while trapped in a fog of uncertainty. From the little we know, it is clear that intellectual-property rights must continue to play a role, at least for now. On the other hand, pharmaceutical firms are arguably making vastly larger profits than needed to sustain their incentive to innovate (especially given how much of their IP has resulted from publicly funded research). In large pandemics such as the current one, we should compensate drug companies with lump-sum payments to cover costs, revoke some of their patents, and allow generic firms to mass-produce essential vaccines.”
III. WHAT WE ARE WATCHING:
WHO member states information session on Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) and Local Production: May 4
WHO Information session on Universal Health and Preparedness Review (UHPR): May 5
General Council Meeting WTO: May 5-6
WHO Informal consultation on the proposed draft agenda item 17.1 Strengthening WHO Preparedness for and Response to Health Emergencies (organized by the EU : May 6
Also check out: Commercial Determinants of Health and the WHO: Conflicts of Interest at the New WHO Foundation: Podcast via Movendi International
IV. THE WEEK IN TWEETS
Jesse Bump, a faculty at Harvard School of Public Health, has a useful reminder for the global health community.
A WHO official calls out McKinsey.
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